Smarter Growth Matters
Who’s checking your promotional pieces?
By: Joe Hage- Medical Devices Group Leader
Aug 11-12, Boston: MDMS, the Medical Device Marketing/Sales Workshop
Life science companies have paid multi-billion-dollar fines resulting from non-compliant promotion. FDA requires companies to have a system in place to ensure that their promotions meet FDA expectations.
Big device companies have an internal Promotional Review Committee (PRC) or a Medical Legal Review (MLR) Committee to review external-facing pieces. MLRs typically have three core members:
- Medical: They typically work in the Medical Affairs department and often have doctorates in Pharmacy, Medicine, or a PhD in the life sciences. They review for FDA and Federal Trade Commission (FTC) compliance.
- Legal: They typically work in the legal or compliance departments and often are attorneys with a Juris Doctor degree. They evaluate if the piece violate laws including HIPAA, the False Claims Act, Anti-kickback law, preexisting agreements, etc.
- Regulatory: These individuals are often well-versed in FDA requirements and review claims in the context of FDA expectations.
So that’s for the big firms. What are the rest of you – who can’t afford full-time medical and legal teams – doing for MLR reviews?
I learned you can outsource the entire MLR function. http://medgroup.biz/outsource-MLR is one place that does it, you may know of others.
In Kulkarni’s case, he has medical, legal, and regulatory groups to help in concept review and campaign development.
“Are you prepared for your Commercial Loan?”
Are you looking for non-dilutive capital? Need to leverage an equipment purchase? Looking to purchase rather than lease your commercial space? If you are answering “yes” to those questions, you are most likely shopping for a commercial loan. You may think that shopping a commercial loan is the most important part of the process. Certainly, finding a financial institution that understands your business and is interested in helping you leverage your growth is important and so are the terms of the loan. However, if you get to that point without being prepared for your commercial loan it can result in lengthy delays, increased closing costs, and potentially an institution’s refusal to fund the loan.
Commercial loans are often used to fund major capital expenditures, cover short term cash flow shortages, and support ongoing operational costs. Due to the status of the equity market, many financial institutions are starting to become creative with their funding mechanisms. With some loans you may see elements of equity rather than just straight debt – especially if the company is not asset heavy. Nonetheless, the due diligence process for the loan will be fairly the same. Here are some things to do in advance of shopping the loan to make for a smooth transaction:
- Raise the topic of the loan with your Board of Directors and Shareholders. The Board will need to consent to any loan and, in some instances, shareholders will need to consent as well.
- If you own commercial real estate or are looking to purchase commercial real estate, you will need to ensure that tenants sign an Estoppel Certificate typically provided by the lender. In Speak with existing or future tenants to ensure they will continue to lease the space. Most likely the loan will be conditioned on the percentage of occupied space the building has and the rent that space produces. Furthermore, you will need tenants to execute documents to be included at closing.
- Conduct UCC and Federal and State Tax lien searches to ensure that previous liens have been properly dissolved. These will also be done by the lender but, are helpful to do yourself before hand to make sure you can take care of any issues that may come back in the search before the lender finds them.
- Ensure that your business is in good standing in the state in which it is organized and any foreign jurisdictions in which it operates. Lender will require certificates of good standing to close the loan. If you have failed to file annual reports and/or pay annual entity taxes, then you will need to file those in order to obtain such certificates.
- Inform your insurance company of the loan and have evidence of coverage for the closing. It would also be advantageous to speak with your lender regarding the coverages/limits they will require to fund the loan.
- Ensure your financials are in order. Depending on the size of the loan, lender may require audited or certified financials. At the very least you will need provide a P&L, Balance Sheet, Statement of Cash Flow, Income Statement, and previous 3 years of tax returns.
- Ensure your capitalization chart is current.
- Ensure your inventory, if any, is accurately reflected in your tracking system.
- Ensure your accounts receivable is accurate and is not laden with bad debts.
- Produce a listing of all intellectual property.
The Massachusetts Pay Equity Act: What Employers Need to Know.
On August 1, 2016, Massachusetts enacted the Pay Equity Act, which significantly changes existing law surrounding compensation. The new law aims to close the wage gap between men and women. There are several key parts of the law that employers in Massachusetts need to be aware of.
1. Do not request salary history from job applicants.
Employers frequently request salary history from applicants. They do this to determine how much to pay an applicant, and to find out whether they can afford an applicant before going through a full interview process. But by setting an applicant’s salary based on what they previously made, an unfairly low salary can potentially follow an individual throughout their career. The provision, which is the first of its kind in the country, is designed to break this cycle. It prohibits an employer from requesting compensation history during the application process.
An employer, however, can confirm previous wage or salary history after “an offer of employment has been negotiated and made to the prospective employee.” Additionally, nothing will prevent an employer from verifying prior wage and salary information if the applicant “has voluntarily disclosed such information.” And nothing prevents an employer from asking what salary an applicant seeks.
2. Do not require employees to keep their compensation levels secret.
Employers often, either officially, or unofficially, discourage employees from discussing their wages. Under the new law this is no longer allowed. Only employees whose jobs involve access to other employee’s wage information may be precluded from discussing other employees’ compensation, unless they receive prior written consent from the employee whose information is sought or requested.
3. Make sure that “comparable work” is paid equally.
The statute requires that “comparable work” be compensated the same. That a job has a different description or title is not determinative. Work is considered “comparable” if it is “substantially similar in that it requires substantially similar skill, effort and responsibility and is performed under similar working conditions.” Compensation for “comparable work,” however, can be different if the variation is based on a merit system, a seniority system, a system based on production levels, geographic location, travel, or education and training if it is reasonably related to a specific job. Seniority cannot factor in leave due to a pregnancy-related condition or other protected family or medical leave.
4. Do not retaliate.
The statute prevents an employer from discharging or retaliating in any way against an employee who opposes any practice prohibited by the statute, who makes a complaint or files suit under the statute, who testifies or participates in an investigation or proceeding, or who discusses wages.
5. Evaluate your pay practices now to avoid claims resulting in double damages and attorney’s fees.
A plaintiff who wins a lawsuit under the new law is entitled to recover their unpaid wages and liquidated damages in an amount equal to those unpaid wages. A successful plaintiff will also be able to recover their reasonable attorneys’ fees and costs.
To avoid exposure to these possible damages, Massachusetts employers should analyze and, if appropriate, modify their existing pay practices before the new law goes into effect in July 2018. As an added incentive to engage in this review, the statute provides an affirmative defense for any employer who within the previous three years completes a self-evaluation of its pay practices, in good faith, and can demonstrate that reasonable progress has been made to eliminate gender based pay inequality. If the evaluation was not “reasonable in detail and scope” the employer will not be entitled to an affirmative defense, but will still avoid liquidated damages.
FGD Client Highlights
Advanced Practice Strategies (APS) is a technology company that works with organizations to build the best patient care teams. Through our two solutions Prophecy and GNOSIS, organizations focus on their most important resource – their people. Our data-driven insights help the nation’s leading health systems reduce turnover, manage risk, and improve outcomes so they can deliver safer, more consistent patient care. Our assessment-based hiring, learning, and engagement analytics enable healthcare leaders to understand team proficiency at the individual, hospital, and system levels. This allows them to identify, place, and onboard the best clinicians; engage doctors and nurses with evidence-based, personalized learning; and measure, understand, and improve team proficiency.
FGD Law actively supports quality of life endeavors within the communities our colleagues live and work. The annual Biddeford-Saco ArtWalk is a favorite of all our team. The concept is based on Portland, Maine’s successful “First Friday”. The downtown group ‘Heart of Biddeford’ and other volunteers have grown it into an ongoing monthly event – taking place on the last Friday of each month, from April to October.
Recently, FGD hosted the work of Robin Swennes. The show, held on August 26th, consisted of abstract paintings utilizing the medium of acrylics on wood. This is a slight change for the usual Maine themes we are used to seeing from Robin. They are quite beautifully done.
Furman Gregory Deptula Welcomes Denise A LaGasse as Attorney at Law
Ms. LaGasse joins Furman Gregory Deptula with extensive experience in software engineering, business, law and academic research. Denise also works with promising early stage as well as more mature technology companies to create a path to commercial success. She has also worked closely with venture capital groups and private investors making funding decisions for very early stage technologies of various kinds. In the past 10 years, she has closed medical device and biologic deals totaling over $800M. As Director of Digital Medicine at the Mount Sinai Medical Center in NYC, she set the strategy for high performance exoscale data analytics research collaboration between Mount Sinai and IBM’s Watson Healthcare Group. Previously, she worked for Hewlett Packard in a variety of managerial, technical, business development, and legal positions, related to product development of world-class technologies, from early stage to first customer shipment and support. Denise has also been in private practice. Denise received her J.D. from the University of New Hampshire and a PH.D from the University of Pennsylvania.